Validation Engineer

Responsibilities:

• Develop URS, SIC and SRA for new and existing aseptic facilities and equipment.
• Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications.
• Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions.
• Ensure all documentation is compliant with regulatory requirements and internal quality standards.
• Conduct risk assessments and implement mitigation strategies for aseptic processes.
• Ability to work closely and effectively with other work groups to successfully complete projects on time and thoroughly.
• Work independently or within a team environment.
• Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the Company.
• Proficient in the use of word processing, spreadsheet, and presentation software programs. Proficient in use if Kaye Validator AVS and Val Probe Systems.
• Knowledge on following equipment qualifications:
  Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units Tanks, Requalification of CTU's.
• Develop and implement validation plans for computerized systems, ensuring that systems are compliant with regulatory standards and internal policies.
• Conduct risk assessments to identify potential issues related to system functionality and data integrity.
• Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports that demonstrate compliance with regulatory requirements.
• Execute CSV protocol, to verify that systems function as intended.
• Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity.
• Excellent interpersonal skills.
• Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company.
• Comprehensive knowledge of pharmaceutical manufacturing equipment and processes.
• Ability to work closely and effectively with other work groups to successfully complete projects on time and thoroughly.

• Bachelor's degree preferably in Engineering or Science discipline.
• 3 - 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment.
• Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs.